Dempfle Carl-Erik, Suvajac Nenad, Elmas Elif, Borggrefe Martin
Mannheim University Hospital, I.Department of Medicine, Theodor Kutzer Ufer 1-3, D-68167 Mannheim, Germany.
Thromb Res. 2007;120(4):591-6. doi: 10.1016/j.thromres.2006.10.020. Epub 2006 Dec 18.
D-dimer is an indicator for in vivo fibrin formation, reflecting the formation of fibrin crosslinked by factor XIIIa. D-dimer assays are frequently used in emergency situations, such as diagnosis of venous thrombosis and pulmonary embolism, or disseminated intravascular coagulation. In these conditions, short sample turnaround times are essential. The PATHFAST D-dimer assay allows rapid quantitative measurement of D-dimer in plasma and whole blood. The study shows an excellent correlation between whole blood and plasma measurement of D-dimer both in the high range, as well as in the normal range. Intra-assay and inter-assay coefficients of variation (CV) were below 10%. The upper limit of normal (ULN = mean value measured in 100 samples from healthy blood donors + 2 x S.D.) was approximately 1 microg/ml FEU, using the assay-specific calibration. The maximal value measured in 20 replicates of calibrator 1 containing no D-dimer antigen was 0.00052 microg/ml FEU, and this 10-fold lower than the declared detection limit of 0.005 microg/ml FEU. In conclusion, the PATHFAST D-dimer assay is the first automated fully quantitative D-dimer assay, which can use plasma and whole blood as sample materials in parallel.
D - 二聚体是体内纤维蛋白形成的一个指标，反映由因子XIIIa交联的纤维蛋白的形成。D - 二聚体检测常用于紧急情况，如静脉血栓形成、肺栓塞或弥散性血管内凝血的诊断。在这些情况下，短的样本周转时间至关重要。PATHFAST D - 二聚体检测可对血浆和全血中的D - 二聚体进行快速定量测定。该研究表明，在高值范围以及正常范围内，全血和血浆中D - 二聚体的测量结果具有良好的相关性。批内和批间变异系数（CV）均低于10%。使用特定检测方法的校准，正常上限（ULN = 从健康献血者的100个样本中测得的平均值 + 2×标准差）约为1微克/毫升FEU。在不含D - 二聚体抗原的校准品1的20次重复测量中，测得的最大值为0.00052微克/毫升FEU，这比声明的检测限0.005微克/毫升FEU低10倍。总之，PATHFAST D - 二聚体检测是首个自动化的全定量D - 二聚体检测方法，它可以同时将血浆和全血作为样本材料使用。
